1. Field of the Invention
The present invention relates generally to dietary supplements, and, more particularly, to methods of preparing and administering a blend of Kava root extract and other relaxing herbs to reduce daily stress and anxiety in adults.
2. Description of Related Art
Throughout history, humans have ingested and otherwise consumed a wide variety of substances to effect relaxation, stress reduction, and an overall sense of well-being and tranquility. Examples of such substances include alcohol, marijuana, and prescription drugs such as valium. However, many such substances have significant undesirable side effects, including impairment of mental faculties, involuntary sleep, and the likelihood of user addiction. Thus, many relaxants are unsafe, especially for long-term usage.
One relaxant that does not typically exhibit any significant side effects is an extract from the Kava-kava root (hereinafter "Kava root"), which consists of the dried rootstock and/or shoots of Piper methysticum Forst (Family: Piperaceae). The Kava root extract is known to induce general relaxation in humans when orally ingested. An aqueous macerate of the Kava root known as "kava" or "kawa" has been used on islands in the South Pacific in social gatherings and religious rituals for three thousand years.
In recent years, the Kava plant has been scientifically scrutinized, with many of its active constituents being identified. The psychoactive ingredients of the Kava root have been identified as kavalactones, also known as kavapyrones. A total of fifteen kavalactones have been identified to date, including kavain, dihydrokavain (a.k.a. marindinin), methysticin, dihydromethysticin, yangonin, and desmethoxyyangonin. These compounds are neutral, nitrogen-poor compounds that may be specifically referred to as substituted d-lactones and substituted .alpha.-pyrones. The lactone ring is substituted by a methoxy group in the C-4 position, and the difference in the compounds lie in the substitution by a styryl residue (e.g., yangonin, desmethy-oxyyangonin, kavain, and methysticin) or by a phenyl residue (e.g., dihydrokavain and dihydromethysticin).
The particular kavalactones in a Kava root extract vary depending upon its origin. Further, the particular kavalactones present depend upon whether, in addition to rhizome parts, roots and stems of the plant are included in the extract. High quality extracts of the Kava root are sold based upon the total kavalactone content, rather than upon analysis of the individual lactones contained therein. The concentration ranges of total kavalactone levels in the Kava root extracts employed, e.g., in Germany are generally within the range of 30 to 55 wt %.
The Kava root extract lactones provide an anxiolytic effect, relieving nervous anxiety, tension, and restlessness, with their efficacy as a relaxant having been tested in clinical trials. The kavalactones also effect muscle relaxation. Studies have also shown that average single doses of Kava do not impair neurophysiological activity, as evidenced by such measuring indicia as recognition rates, event-related brain potentials, and driving ability (see, e.g., Munte et al, "Effects of Oxazepam and an Extract of Kava Roots (Piper methysticum) on Event-Related Potentials in a Word Recognition Task", Neuropsychobiology 1993:27, pp. 46-53 and Russell et al, "The Effect of Kava on Alerting and Speed of Access of Information from Long-term Memory", Bulletin of the Psychonomic Society, 25(4), pp. 236-37 (1987)). Further, kavalactones are non-addictive and do not induce involuntary sleep or effects of drunkenness.
Traditionally, Kava root is prepared for human consumption by pulverizing the plant material, mixing with water, and drinking the resulting liquid. Modern Kava root extracts are manufactured using ethanol as a solvent, as the kavalactones are readily soluble in ethanol. The extracted materials are in the form of a yellowish brown paste or powder, which is then tested to assure proper levels of kavalactones.
Today, Kava root extract is widely available in Germany and other European countries as an herbal supplement in the form of tablets, capsules, and dragees made of pharmaceutical grade extract. Ingestion of kavalactones in the form of drops is not desirable, given their bitter soapy taste. Typically, Kava root extract is commercially available in Europe with single doses containing 200 to 250 mg of extract with 30 wt % kavalactones, or about 60 to 75 mg kavalactones, and normal daily usage would be one to three capsules. Examples of available commercial extracts include the following trade designations, with the standardized milligrams of kavalactones in a dose indicated parenthetically if known: Antares.RTM.-120 (120 mg), Ardeydystin.RTM. forte (50 mg), Kava von ci (40 mg), Kavasedon.RTM. (25 mg per mL), Kavasporal.RTM. forte (50 mg), Kavatino.RTM. (25 mg), Laitin.RTM.-100 (70 mg), Kavain, Somnuvis.RTM., Hewepsychon.RTM. duo (at least 24 mg per mL), Valeriana comp Hevert.RTM., and Cefakava.RTM. 150 (35 mg) (see M. Schmidt, "A Medicinal Plant from the South Seas", PTA heute, Vol. 8, No. May 5, 1994)).
Although ingestion of the Kava root extract does not typically exhibit the serious side effects of other common relaxants, it likewise should not be used in the case of pregnancy or lactation. A known possible side effect of prolonged ingestion of the Kava root extract is a temporary yellow discoloration of the skin and appendages, upon observance of which one should cease intake of the herb. Other rare side effects include allergic skin reactions, gastrointestinal complains such as nausea and diarrhea, accommodation disorders (disorders of the ability of the eye to adjust to see at various distances), dilations of the pupil, and disturbances of the oculometer equilibrium.
Given the long-established beneficial calming effect of the Kava root extract and its rare incidence of associated side effects, it would be desirable to provide the Kava root extract in a dietary supplement improved over that already commercially available. The dietary supplement should enhance the general relaxant qualities offered by the Kava root extract without introducing any harmful side effects. It should be inexpensively manufactured and comply with all applicable governmental regulations.